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2022-10-24
To address the special concerns that arise in the clinical development of antibody-drug conjugates for cancer treatment and to guide enterprises in conducting more scientifically sound clinical research and development, the Center for Drug Evaluation has prepared the “Technical Guidance Principles for Clinical Development of Antibody-Drug Conjugates for Cancer Treatment.” A draft for public comments has been formulated and is now available for reference by those involved in drug research and development.
2022-09-22
To provide scientific guidance for enterprises in the rational development of combination drugs and further clarify the technical standards for clinical trials, the Center has drafted the “Technical Guidance Principles for Clinical Trials of Combination Drugs (Exposure Draft).” After internal discussion within the Center, the exposure draft has now been finalized.
2022-09-22
To guide sponsors of clinical trials in conducting protocol amendments during clinical trials in a standardized manner, under the guidance of the National Medical Products Administration, the Center for Drug Evaluation has developed the “Technical Guidance Principles for Protocol Amendments During Clinical Trials (Trial)” (see attachment). In accordance with the requirements set forth in the “Notice of the Comprehensive Division of the National Medical Products Administration on Issuing Procedures for the Publication of Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, these principles are hereby promulgated and shall take effect from the date of their publication.
MA Results Release | Huasen Pharmaceutical—Terazosin Hydrochloride Capsules Approved!
2022-03-23
Congratulations to Chongqing Huasen Pharmaceutical Co., Ltd. on receiving the “Drug Approval Notice” for its Terazosin Hydrochloride Capsules (2mg) project!
2021-04-15
To further guide and standardize sponsors’ use of real-world data to generate real-world evidence in support of drug development, the Center for Drug Evaluation has organized the drafting of the “Guiding Principles for Real-World Data Used to Generate Real-World Evidence (Trial)” (see attachment).
2021-02-23
Due to the company's growth, Eurasia Huizhi (Beijing) Medical Research Co., Ltd. officially established a Shanghai office on February 19, 2021.
2021-01-18
To further standardize and guide the quality research of new traditional Chinese medicine (TCM) products and promote high-quality development of the TCM industry, the Center for Drug Evaluation, under the guidance of the National Medical Products Administration, has organized the drafting of the “Technical Guidance Principles for Quality Research of New TCM Products (Trial)” (see attachment).
A seminar on a clinical study protocol for non-small cell lung cancer was successfully held.
2021-01-05
During the period of regular COVID-19 prevention and control, our company successfully held an online proposal discussion meeting!
2021-01-04
To further standardize the management of clinical research, enhance the quality of clinical studies, promote the healthy development of clinical research, and improve the capacity of medical and health institutions in diagnosing, treating, preventing, and controlling diseases, we are now publicly soliciting comments from the public.
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